Regulatory Affairs and Medical Devices Task Force

Description

In this task force, high-level experts in this field discuss the latest developments in the regulatory framework for medical devices. They exchange key insights and interpretations of the EU medical devices framework and identify areas where the BioMed Alliance can provide input and expertise to enhance the safety of medical devices in Europe. They also explore opportunities for reaching out to key stakeholders and organisations in the medical devices field, both within Europe and beyond.

Experts

Highlights

Medical experts united on 11 February 2019 to improve scientific scrutiny of evidence for approval of high-risk medical devices in the European Union

On 11 February, experts from the Biomedical Alliance in Europe (BioMed Alliance) advised the Joint Research Centre (JRC) of the European Commission in Ispra, Italy, on the clinical evaluation of high-risk medical devices. See the press release for more information.

BioMed Alliance Recommendations on the role of Scientific bodies under the new EU medical device legislative framework

The BioMed Alliance has provided recommendations and input to ensure that independent advice is available to regulators responsible for the new EU legislative framework for medical devices and in vitro diagnostics. Find more information here.

The BioMed Alliance together with the ESC and EFORT organised a joint workshop on Medical Device Registries on 17 June 2019 in Brussels. The meeting facilitated a discussion between EU regulators, healthcare professionals, industry and patient representatives on both regulatory and clinical needs in relation to medical device registries.

BioMed Alliance Joint Letter with EPF and ESC calling for investment to ensure MDR is implemented on time

The Biomedical Alliance in Europe released an open letter to EU Health Ministers with the European Patients Forum (EPF) and the European Society of Cardiology (ESC) on 7 June calling for urgent investment to ensure that the EU Medical Devices Regulation (MDR) is implemented on time. Find the open letter here

Participation MDCG Working Groups

BioMed Alliance representatives also participate in different stakeholder working groups of the Medical Device Coordination Group, which advises the European Commission and helps ensuring a harmonised implementation of medical device regulations in member states.

European Commission recruits experts for evaluation medical devices

The European Commission has opened a call for experts to be appointed as members of the expert panels for medical devices as described in the Medical Device Regulation. By participating, experts will contribute to ensuring the safety of medical devices. The call is open until 10 November 2019 for all eligible applicants with expertise related to medical devices. Read more here.